ViiV HEALTHCARE PRESENTS NEW DATA DEMONSTRATING POSITIVE REAL-WORLD IMPACT OF ITS INNOVATIVE LONG-ACTING INJECTABLES FOR HIV AT IAS 2025

London, 8 July 2025 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of abstracts from its innovative HIV treatment and prevention portfolio at the International AIDS Society 2025 Conference (IAS 2025) in Kigali, Rwanda. Key data will highlight the long-term effectiveness of Vocabria & Rekambys, (branded as Cabenuva in the US, Canada and Australia) the company’s complete long-acting injectable regimen for treatment; evaluate patient preference for long-acting injectables compared to daily oral therapy; and measure benefits of long-acting injectables in tackling common challenges associated with taking daily pills, including stigma and adherence.

Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “Our extensive real-world insights about CAB+RPV LA for HIV treatment and CAB LA for HIV prevention demonstrate how long-acting injectables are redefining the way we approach HIV care and management in broad populations. The new real-world and implementation data at IAS 2025 further reinforce their effectiveness, safety and tolerability, and underscore our commitment to delivering therapies that meet the evolving needs of people impacted by HIV, offering flexibility and choice beyond daily oral treatment.”

Key data to be presented at IAS 2025 by ViiV Healthcare and its study partners include:

New data assessing preference and choice to switch to CAB+RPV LA after attaining rapid viral suppression: First data from the phase IIIb VOLITION study assessed preferences and experiences among ART-naive adults offered the option to switch to CAB+RPV LA after achieving rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC).¹

Growing body of real-world effectiveness data for CAB+RPV LA in broad range of populations: New data will be presented on outcomes including effectiveness, adherence, and satisfaction with CAB+RPV LA, from several real-world studies, including COMBINE-2, and two-year data from CARLOS and BEYOND.^2,3,4,5 In addition, two analyses from the OPERA cohort will focus on the effectiveness of CAB+RPV LA in real-world settings for treatment-experienced adults with viremia at therapy initiation.^6,7

New implementation data on acceptability and benefits of CAB LA for PrEP: Data from the PILLAR and EBONI implementation studies will focus on participant experiences with CAB LA implementation among men who have sex with men and transgender men, as well as healthcare provider experiences implementing CAB LA for Black women, respectively.^8,9

New effectiveness data for DTG/3TC in different populations: New data from VOLITION evaluate the efficacy of DTG/3TC in achieving rapid virologic suppression in a diverse treatment-naive population.¹⁰ Data from investigator-led, ViiV Healthcare-supported studies, D2ARLING and SUNGURA will also be presented, including D2ARLING’s comparison of DTG/3TC effectiveness to other regimens in the presence of transmitted resistance mutations, and an analysis from the SUNGURA study including safety and efficacy data in virally suppressed older people living with HIV switching to DTG/3TC from BIC/FTC/TAF.^11,12

Positive Perspectives wave three data highlighting the importance of community perspectives in treatment outcomes: Interim results from wave three of the Positive Perspectives study will be presented, showing how shared decision making and treatment satisfaction are linked to treatment outcomes and self-rated health in specific sub-group analyses.¹³ Additionally, the continued need to improve awareness, belief and confidence in U=U will be presented.¹⁴

DOVATO (dolutegravir and lamivudine) tablets
Professional Indication and Important Safety Information

INDICATION

DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1:

EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

CONTRADICTIONS

• Do not use DOVATO in patients with previous hypersensitivity reaction to dolutegravir or lamivudine
• Do not use DOVATO in patients receiving dofetilide

WARNINGS AND PRECAUTIONS 

Hypersensitivity Reactions:

• Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
• Discontinue DOVATO immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

• Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors
• Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of DOVATO. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
• Monitoring for hepatotoxicity is recommended

Embryo Fetal Toxicity:

• Assess the risks and benefits of DOVATO and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects
• Pregnancy testing is recommended before initiation of DOVATO. Individuals of childbearing potential should be counseled on the consistent use of effective contraception

Lactic Acidosis and Severe Hepatomegaly With Steatosis:

• Fatal cases have been reported with the use of nucleoside analogs, including lamivudine.
• Discontinue DOVATO if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of DOVATO and other drugs may occur (see Contraindications and Drug interactions).

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of DOVATO.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2%, all grades) with DOVATO were headache (3%), nausea (2%), diarrhea (2%), insomnia (2%), fatigue (2%), and anxiety (2%).

DRUG INTERACTIONS

• Consult full Prescribing Information for DOVATO for more information on potentially significant drug interactions
• DOVATO is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
• Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir
• Administer DOVATO 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, DOVATO and supplements containing calcium or iron can be taken with food

USE IN SPECIFIC POPULATIONS

• Pregnancy: There are insufficient human data on the use of DOVATO during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. Advise individuals of childbearing potential of the potential risk of neural tube defects. Assess the risks and benefits of DOVATO and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy or if pregnancy is confirmed in the first trimester
• Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
• Females and Males of Reproductive Potential: Pregnancy testing is recommended before initiation of DOVATO. Counsel individuals of childbearing potential taking DOVATO on the consistent use of effective contraception
• Renal Impairment: DOVATO is not recommended for patients with creatinine clearance <30 mL/min. Patients with a sustained creatinine clearance between 30 and 49 mL/min should be monitored for hematologic toxicities, which may require a dosage adjustment of lamivudine as an individual component
• Hepatic Impairment: DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C)

For more information, please see full US Prescribing Information for DOVATO:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/DOVATO/pdf/DOVATO-PI-PIL.PDF

About Rekambys (rilpivirine)

Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.

Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).

Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.